Regulatory Affairs Specialist
1 tydzień temu
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
What You Can Expect
As a Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies, timely execution of registrations for market authorization, reviewing labeling and promotional materials, providing guidance and consultation on regulations to global affiliates/distributors, interacting with government authorities, participating in industry working groups, and maintaining the Quality Management System requirements.
An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations and their application is required. This position requires subject matter expertise.
How You'll Create Impact
Works closely with regional, country, global cross-functional teams to drive new registrations, ensure registration maintenance, and compliance with regulatory requirements, the Quality Management System, and all other applicable quality and regulatory standards:Communicates and executes regulatory strategies and plans. Supports development of country/regional positions on regulatory risk-benefit. Supports project teams to ensure regulatory requirements are incorporated and met throughout the product life cycle.Acts as a liaison with various functional, regional, and global teams.Provides support in obtaining documentation for registration dossiers and responses to queries from the regulatory authorities.Prepares registration dossiers (new, renewals, re-registrations) and responds to queries from the regulatory authorities; reviews registration dossiers prepared by Consultants, Regulatory Associates/Specialists.Assists with data entry, maintenance of regulatory files, and tracking databases to ensure availability of accurate company regulatory information; supports maintenance of registration license data for distribution control.Participates in internal/external audit activities; coordinates audit corrective actions.Supports reimbursements, tenders, government notifications, regulatory approvals, site certifications, Quality field actions, PMS, audits/inspections, etc. as needed. Understands and influences the medical device regulatory environment by leveraging relationships with regulatory authorities and industry groups. Participates in industry working groups. Interprets and applies regulations to business practices and provides regulatory input, advice, and guidance to the organization. Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products, post market activities, and processes. Responsible for regulatory compliance (e.g., establishes Zimmer Biomet Regulatory Affairs policies/procedures and ensures compliance to them; supports review of advertising and promotional materials for compliance to local requirements).
What Makes You Stand Out
Competent English language skills (fluency in reading, writing, listening, and speaking) Strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory authorities Knowledge of medical device products, regulations, standards; ability to interpret and apply them Ability to support multiple projects with guidance; handling assignments from low to medium complexity Ability to build relationships with other areas of the organization (i.e. marketing, clinical) Ability to identify and assess business risks to develop regulatory strategies Responsible, professional, detail oriented Strong computer skills
Your Background
You hold a Bechelor’s Degree in life sciences, technical (engineering), or related field (an advanced degree is preferred). In addition, you have a proven track record of at least 3 years in a Regulatory Affairs position (or equivalent experience) in the medical device industry. A combination of education and experience may be considered.
Ideally you have gained experience in the areas of device, drugs, biologics regulations. You also have a working knowledge and experience applying medical device regulations, standards, and guidance documents.
EOE/M/F/Vet/Disability
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